Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Endocrine, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/20/2018 |
| Start Date: | February 2009 |
| End Date: | June 2012 |
A Randomized Comparison of the Acute Effects of Olanzapine and Ziprasidone on Whole Body Insulin Sensitivity in Healthy Volunteers
Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in
comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men,
measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production
(glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of
disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of
appearance [Ra]).
We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in
insulin sensitivity.
Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling
pathways in antipsychotic naïve healthy young men.
We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in
insulin signaling.
comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men,
measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production
(glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of
disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of
appearance [Ra]).
We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in
insulin sensitivity.
Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling
pathways in antipsychotic naïve healthy young men.
We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in
insulin signaling.
See brief description
Inclusion Criteria:
- Males aged 18-45 years
- BMI approximately ≥ 25 and < 35
- insulin approximately ≥ 15 µU/ml or triglyceride approximately ≥ 130 mg/dl
Exclusion Criteria:
- Any DSM-IV Axis I diagnosis
- prisoners
- any serious medical disorder (i.e. metabolic diseases, type 1 or 2 diabetes mellitus,
endocrine disease, coagulopathy, clinically significant anemia, acute infection)
- taking prescription medications
- non-sedentary lifestyle with > 3 hours of exercise per week
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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